Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC

UMIN ID: UMIN000002073

Registered date:01/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 2007/05/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): hospitalization therapy administration via the implanted port of Cisplatin/lipiodol suspension(50mg/body,ia,day1,8) and 5-FU(1250mg/body/day, cia day1-5,8-12) into the hepatic artery every two weeks. outpatient therapy : The case that chemotherapy by the hospitalization finished,leaves the hospital if possible. Administration via the implanted port of Cisplatin/lipiodol suspension(10~50mg/body,ia,day1)and 5-FU(500~1250mg/body/day,cia,day1-5)into the hepatic artery every two weeks.Repeat 10 courses.

Outcome(s)

• Primary Outcome: Progrssion free survival
• Secondary Outcome: Overall survival response evaluation complicasion

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.previous chemotherapy or TAE 2.Previous operation or RFA or PEIT within one year 3.Extrahepatic metastasis or nodes metastasis 4.Concurrent infections(without hepatitis virus) 5.Active double cancers 6.Medical history of severe hypersensitivity. 7.Pregnant,lacting women or women with suspected pregnancy. 8.Inappropriate patients for this study judged by physicians.

Related Information

• Primary Sponsor: Division of Gastroenterology,Kurume University School of Medicine
• Source(s) of Monetary Support: None